Posted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.
This guidance clarifies how FDA determines whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks.
It finalises the draft guidance, issued on 21 September 2016.
